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P.K. Kaiser, TAP Study Group; Five-Year Results of Verteporfin Therapy for Subfoveal CNV Due to AMD: Third Year of an Open-label Extension of the TAP Investigation . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1099.
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Purpose: To report 5-year results from the Treatment of AMD with Photodynamic therapy (TAP) Investigation that include 3-year results from an open-label extension evaluating verteporfin therapy (Visudyne®, Novartis AG) in AMD patients with classic-containing subfoveal CNV for vision outcomes of patients with predominantly classic lesions and safety outcomes for all participants. Methods: Patients who completed 24 months of the TAP Investigation and who it was judged might benefit further from verteporfin therapy, were enrolled into the TAP Extension. Methods were similar to those in the TAP Investigation, except extension patients with fluorescein leakage from CNV received open-label verteporfin therapy irrespective of their treatment assignment (verteporfin or placebo) at baseline. Results: The enrolled participants included 124 (78%) of the original 159 verteporfin-treated patients with lesions composed of predominantly classic CNV at baseline, of whom 93 (58%) of the 159 completed the month 48 examination. Visual acuity measurements were done for 92, 90, and 93 patients at month 24, 36, and 48, respectively. A loss of ≥15 letters of visual acuity from baseline occurred in 33 (36%) at month 36, and 40 (43%) at the month 48 examination, with a mean letter score loss of 8.7, 9.9, and 10.4, respectively. During the extension no additional safety concerns were noted in any patient receiving verteporfin. Two patients originally assigned to placebo had acute severe vision decrease (loss of ≥20 letters of visual acuity within 7 days of treatment) in the study eye between months 24 and 36. No additional case of acute severe vision decrease was reported between months 36 and 48. Vision and safety outcomes through the month 60 examination will be presented. Conclusions: Vision outcomes remained relatively stable for verteporfin-treated patients with predominantly classic lesions from the month 24 to the month 48 examination. Caution in the interpretation of these results appears warranted in the absence of a comparison with an untreated group during the extension and because not all patients in the TAP Investigation participated in the TAP Extension.
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